Abstract

Natrajan S. Iyer, *Aditya Prakash Sharma, Ajay Bhardwaj, Rinki Dani and Rekha Mehta

ABSTRACT

As automation in pharmaceutical manufacturing has become compulsory to avoid batch to batch variation. In doing so dependency in automation has increased by many folds. As we depend on automation many physical parameters are taken for going from one stage to another stage. Example:- going from washing of bungs to sterilization of bungs through moist heat auto sterilizer. These automated processes are controlled by programmable logic controllers (PLC). They work in certain sequence and with high amount of security so that the process is not deviated from a validated method. To ensure the PLC and other automated equipments operates in validated sequence batch after batch without any deviation from a validated process. Hence a guideline was made by regulatory authority as 21 code of federal regulation part-11 to ensure the basic compliance by one self this article is written.